Assuring quality of oligonucleotide APIs and DPs


Founder and Principal Consultant, Carmody Quality Solutions, LLC, USA
Member, Society of Quality Assurance (SQA); New England Regional Chapter Society of Quality Assurance (NERCSQA);
Association of GXP Excellence (AGXPE)


The development of oligonucleotide therapeutics continues to accelerate with progress in oligonucleotide chemistry and adoption of delivery technologies. This article will discuss the necessary steps to execute to assure quality of your oligonucleotide APIs and DPs, and compliance with agency expectations.

A Roadmap to Quality: Performing CMC Activities with an NDA In Mind
This article discusses necessary steps to execute and assure quality of oligonucleotide Active Pharmaceutical Ingredients (APIs) and Drug Products (DPs), as well as compliance and expectations from regulatory agencies.
The basis of this work begins with “good science” and a grounded understanding of the drug development process.
Responsibilities of Sponsor and Vendors
Most start-up or mid-size life sciences organizations face the challenge of bridging the gap between research and regulated drug development to accelerate the time to market without sacrificing quality. Many of these organizations outsource most, if not all, of the drug development activities. As such, the first step towards accelerating time to market and building quality into the product is knowing that as the Sponsor, you must be the expert about your products, so you can collaborate with vendors appropriately in order to ensure clear communication of responsibilities (see Figure 1).
Sponsors need to share important i ...